Archive

Forum Seminar: The labelling manager

24 and 25 June 2019, Mannheim, Germany - This seminar delivers profound know-how of the labelling process chain from preparation of the package insert, the artwork and the packaging up to GMP-relevant aspects. Afterwards, you are up-to-date with regulatory requirements.

Forum Seminar: Scientific Writing and Reviewing in Regulatory Affairs

9 - 10 April 2019 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: free writing versus regulatory restrictions; editing and proofreading documents; package leaflet - regulatory linguistic restrictions and user-friendly writing.

Forum Seminar: Product information

28 June 2018 in Cologne, Germany, and 4 December 2018 in Berlin, Germany - Product information: SmPC, package insert and labelling

Typographic changes in package leaflets of the European Union based on the example of German versions between 2005 and 2015

Using German package leaflets over the period from 2005 to 2015 as example, the study results show significant improvements, such as the increase in font sizes, line spacing and the more frequent use of highlighting. However, a significant increase in the volume of text has been found.

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Forum Seminar: product information

29 - 29 June in Berlin, Germany, 7 - 8 December 2017 in Cologne, Germany - Product information, including workshop to prepare SmPC, package insert and labelling

Forum workshop: QRD template

26 January 2017, Cologne, Germany - QRD template implementation, company-internal adjustments, practical exercises

Landscape versus portrait format in package leaflets - Which format is more suitable according to readability test results from the PAINT3 study?

The results in the written readability test with 234 participants do not show an advantage of the landscape format over the portrait format. This finding negates the EU readability guideline’s stated preference for the landscape format.

Implementation of the European Union QRD template in package leaflets of centralised approved medicines

Our analysis over 3 years of all English-language package leaflets available on the EMA website showed a significant text increase in package leaflets, whereby one mean reason is the huge text increase of the QRD template.

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Research concerning handling the ongoing volume of text increase in package leaflets

Resource-saving solutions that additionally guarantee a good standard of legibility for package leaflets, such as text compression and targeted paper selection, can be found in the following.

Extensive research published concerning the QRD template

Dr. Anna Wolf finalised her extensive work in February 2015 concerning the QRD template of the European Union, under PAINT-Consult’s supervision at the University of Bonn.

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Opacity study by PAINT-Consult

The results of two investigations of 258 randomly selected German package leaflets show that opacity is a more appropriate tool for assessing paper quality than the paper weight recommended in the readability guideline.

List of MAH representatives in package inserts is no longer required

Since QRD template version 9.1 this list is no longer essential.

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An analysis and evaluation of the development of the QRD human product information template used in package leaflets

Dissertation, 2015

Forum seminar: Labeling, package insert and QRD templates

26 - 27 February 2015, Bonn, Germany - Workshop: experience with readability user testing, using QRD templates

Statement relating to the Excipients Guideline draft on sodium laurilsulfate

Discussion to date: September 2015

Forum seminar: Labeling, package insert and QRD-Templates, Bonn, Germany

Expirience with readability user testing (RUT), using QRD templates

How best to assess paper quality for package leaflets – weight or opacity?

PharmInd, 2015, 77(9):1380-1383

Statement relating to the Excipients Guideline draft on sodium

Discussion to date: May 2015

Forum seminar: Package insert - seminar for experts

Use of sample/reference texts and QRD templates, practical exercises for using the QRD template, readability user testing and bridging studies

Handling the ongoing volume of text increase in package leaflets

Original German title: Handling des steten Textzuwachses in Packungsbeilagen

Forum training: Labeling, package inserts and QRD templates

10 - 12 February 2014, Bonn , Germany - Workshop: use of QRD templates, questions relating to labeling

Forum training: Labeling, package inserts and QRD templates, Bonn, Germany

Use of QRD templates, questions relating to labeling

Readability of the European QRD template - The European QRD template version 8 in comparison to its predecessor and a shorter model template

PharmInd, 2014, 76(8):1312-1322

Move into larger, company-owned premises

Address: Wenigenjenaer Ufer 12, 07749 Jena, Germany

QRD template: Harmonisaton of product information texts

Original German title: QRD-Template: Harmonisierung von Produktinformationstexten

Forum seminar: Labeling, package inserts and QRD templates, Bonn, Germany

Use of QRD templates

12th EGA Regulatory and Scientific Affairs Conference

17 - 18 January 2013, London, United Kingdom - Presentation: Learning from current experience - did readability tests improve the quality of information and satisfy patients' needs?

12th EGA Regulatory and Scientific Affairs Conference, London, United Kingdom

Learning from current experience - did readability tests improve the quality of information and satisfy patients‘ needs?

Patient friendly package inserts under economic and regulatory considerations

Original German title: Patientenfreundliche Packungsbeilagen unter ökonomischen und regulatorischen Gesichtspunkten

Statement relating to the QRD template draft

Discussion to date: July 2012

Pharma Packaging 2012, 6th annual meeting, Berlin, Germany

The new QRD templates for product information

QRD Template texts intended for package inserts - Development from the first QRD template up to the new draft of July 2012

PharmInd, 2012, 74(9):1540-1549

Our ongoing effort, since 1999, to improve the comprehensibility in package inserts continues to yield results.

The Forsa Opinion Research Institute, acting on behalf of the ERGO Insurance Group AG, interviewed 2600 people. The results show that package inserts are the most comprehensible product information in Germany.

Pharma Packaging 2012, 6th annual meeting

14 February 2012, Berlin, Germany - Presentation: The new QRD templates for product information

Statement relating to the QRD template draft

Discussion to date: April 2012

Forum seminar: Labeling, package insert and QRD templates, Bonn, Germany

Using the new QRD templates

How can the package insert be more patient friendly?

Original German title: Wie wird der Beipackzettel patientenfreundlicher?

Two studies of the QRD template published by PAINT-Consult

PAINT-Consult developed a model template with only 200 words, which has significant advantages over the QRD template (PDF). In a second study, the development of the QRD template from 1996 to 2012 was analysed (PDF).

The influence of the European Union's QRD template on the use of package inserts compared with a shorter model template

PharmInd, 2012, 74(1):126-136

Meeting of the Association of the European Self-Medication Industry (AESGP)

6 April 2011, London, UK - Presentation: The "ideal" OTC package insert

Package inserts, ongoing overload

Original German title: Packungsbeilagen immer mehr überfrachtet

Which vaccination makes sense?

Original German title: Welche Impfung ist sinnvoll?

Meeting of the Association of the European Self-Medication Industry (AESGP), London, United Kingdom

The ideal OTC package insert

Pharma Packaging 2011, 5th annual meeting

14 February 2011, Berlin, Germany - Presentation: Readability Guideline and Labelling: Current experience on implementation and readability tests.

Counterfeit medicines and the pseudo-safety

Original German title: Arzneimittelfälschungen und Scheinsicherheit

Reprimand for counterfeit medicines

Original German title: Klatsche für Arzneimittel-Plagiate

Forum seminar: Labeling, package inserts and the coming QRD templates, Bonn, Germany

The coming QRD templates

CMDh position paper: PAINT-Consult's written readability test method is once again acknowledged

CMDh once again recommended PAINT-Consult's written readability test method as an alternative

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Update of the QRD template and resultant changes in package inserts and summary of product characteristics

Original German title: Update des QRD-Templates und daraus resultierende Änderungen in Packungsbeilagen und Fachinformationen

Pharma Packaging 2011, 5th annual meeting, Berlin, Germany

Readability Guideline & Labelling: Recent experience on implementation and readability tests

The package insert - still a "closed book"?

Original German title: Die Packungsbeilage - noch immer "ein Buch mit sieben Siegeln"?

Training program for Chinese Medicines Agency (SFDA)

26 November - 3 December 2010, University of Bonn, Germany - Presentation: Patient information via package inserts within the European Union

Dissertation University of Bonn, Department of Drug Regulatory Affairs

Supervised by PAINT-Consult, Dr. Claudia Hertzsch completed her dissertation relating to: Possibilities and limitations in preparing patient-friendlier package inserts with regard to content, formal design and amount of text.

Ambivalent dosage instructions for children

PharmInd, 2010, 72(4):602-606

The package insert: requirements of the liability law

Original German title: Die Packungsbeilage: Anforderungen des Haftungsrechts

MHRA again confirms acceptance of our written readability test

Inadequate vaccination status of medical and pharmaceutical students

Original German title: Unzureichender Impfstatus von Medizin- und Pharmaziestudenten

Possibilities and limitations of package inserts designed to be patient friendly with regard to content, formal design and volume of text

Original German title: Möglichkeiten und Grenzen einer patientenfreundlicheren Gestaltung von Packungsbeilagen im Hinblick auf Inhalte, formale Gestaltung und Textumfang

New font size requirements in package inserts of medicines

PharmInd, 2010, 72(12):2032-2036

2nd statement relating to the QRD template draft

Discussion to date: October 2010

Training program for Chinese Medicines Agency (State Food and Drug Administration), Bonn, Germany

Patient information via package inserts within the European Union

Too much of a good thing - Package inserts of medicines should be more comprehensible

Original German title: Wenn des Guten zu viel ist - Die Packungsbeilagen von Medikamenten sollen verständlicher werden

Excessive medical information increase in package inserts

International Journal of Clinical Pharmacology and Therapeutics, 2010, 48(12):781-790 Fuchs J et al.

1st statement relating to the QRD template draft

Discussion to date: February 2010

Pharmaceutical Colloquium at the Institute of Pharmacy, Bonn, Germany

User friendly patient information via package inserts - status and perspectives

Tremendous increase of text volume in package inserts

Original German title: Enormer Textzuwachs in Packungsbeilagen

The way forward in package insert user tests from a CRO's perspective

Drug Information Journal, 2010, 44(2):119-129

PAINT3 study

PAINT-Consult completes the PAINT3 study - a readability test study of 271 randomly selected German package inserts with 5091 participants.

Prophylaxis through vaccination: Consultation in the pharmacy

Original German title: Impfprophylaxe: Beratung in der Apotheke

Involve package inserts in the consultation

Original German title: Packungsbeilagen in die Beratung einbeziehen

Vaccination advice at pharmacies in Brandenburg and Mecklenburg-Western Pomerania

Original German title: Brandenburg/Mecklenburg-Vorpommern: Impfberatung in Apotheken

Patient friendly information about medicines in package inserts

Original German title: Patientengerechte Arzneimittelinformation in Packungsbeilagen

European Commission demand a minimum font size of 9pt as recommended by PAINT-Consult

In the readability guideline (PDF) the European Commission stipulated a minimum font size of 9pt as recommended by PAINT-Consult, instead of the previously recommended 12 to 20pt (PDF). This is based on the font size study of PAINT-Consult published in May 2008 (PDF).

The amount of liquid patients use to take tablets or capsules

Pharmacy Practice, 2009, 7(3):170-174

Joint DIA – EMEA – CMD(h) workshop on user testing

5 December 2008, London, United Kingdom - Presentation: The way forward on user testing - CRO's perspective

The major vaccination advice project in Thuringian pharmacies

Original German title: Die große Impfberatung in Thüringens Apotheken

How precisely can tablets be divided?

Original German title: Wie genau lassen sich Tabletten teilen?

Readability test methods, bridging, exceptions

Original German title: Lesbarkeitstest Methoden, Bridging, Ausnahmen

Package inserts - Make it easy for the layman

Original German title: Beipackzettel - Für Laien leicht verständlich

Joint EMEA - CMDh - DIA workshop on package insert user testing, London, United Kingdom

The way forward on user testing - CRO's perspective

Influence of font sizes on the readability and comprehensibility of package inserts

PharmInd, 2008, 70(5):584-592

PAINT2 study

PAINT2 study is accomplished. This is an analysis of 271 package inserts randomly chosen from those available on the German medicine market in 2005.

Swiss Medicines Law

Frequency explanations of side effects developed in the PAINT1 study are recommended throughout the European Union

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Can package inserts be optimised?

Original German title: Sind Packungsbeilagen optimierbar?

Vaccination advice in Mecklenburg-Western Pomerania, Germany

Scientific leadership of the large vaccination advice campaign for pharmacies in Mecklenburg-Western Pomerania (Germany) during 2007, including training courses for pharmacy staff

Bringing order to the paper chaos

Original German title: Ordnung in die Zettelwirtschaft

Importance of package insert information in the European Union - medicinal and pharmaceutical experts questioning results

PharmInd, 2007, 69(2):165-172

The Pharmaceutical Appliance and Epidemiology Research Associations (GAA) 14th annual meeting, Frankfurt/Main, Germany

Is splitting tablets an appropriate method to save medical costs

Plain text instead of expert jargon

Original German title: Klartext statt Fachjargon

Is splitting tablets an appropriate method to save medical costs?

German Medical Science GMS Publishing House, 2007

Beating flu, pneumococci etc. Which vaccinations do I need as a diabetic?

Original German title: Gegen Grippe, Pneumokokken etc.: Welche Impfungen brauche ich als Diabetiker?

Package inserts and their influence on drug safety and therapy success

German Medical Science GMS Publishing House, Oktober 2006

Package inserts - Text must be shorter

Original German title: Packungsbeilagen - Text muss kürzer werden

How should a good package insert look like?

Original German title: Wie muß ein guter Beipackzettel aussehen?

Europe-wide acceptance of the written readability test developed and used by PAINT-Consult

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La provisión de consejo farmacéutico mejora el estado de vacunación de los pacientes

Original English title: The provision of pharmaceutical advice improves patient vaccination status

Statement relating to the IQWIG health information draft

Discussion to date: October 2006

Patient information from the IQWIG

Original German title: Patienteninformationen vom IQWIG

Readability tests for package inserts - in the case of risks and side effects

Original German title: Lesbarkeitstests für Beipackzettel - Zu Risiken und Nebenwirkungen

Statement relating to the Readability Guideline draft 2006

Discussion to date: September 2006

Vaccination advice in Brandenburg, Germany

Scientific leadership of the large vaccination advice campaign for pharmacies in Brandenburg (Germany) during 2007, including training courses for pharmacy staff

Vaccination advice in Thuringia, Germany

Scientific leadership of the large vaccination advice campaign in pharmacies throughout Thuringia (Germany) during 2005, including training courses for pharmacy staff

Vaccination advice in the pharmacy

Original German title: Impfberatung in der Apotheke

The major vaccination advice project in Thuringian pharmacies, Germany

Workshop

The vaccination advice project in Brandenburg pharmacies, Germany

Vaccination advice in pharmacies

A survey of package inserts use by patients

Hospital Pharmacy Europe, 2005, 21(4):29-31

The PAINT-Consult company is formed

Package inserts as medium to convey targeted information and directions for use to patients: Developing and testing a tool to rate and optimise pharmaceutical product package inserts

Dissertation, 2015

Training for employees of pharmacies to carry out the large vaccination advice in Thuringian pharmacies, Erfurt, Germany

Vaccination advice in pharmacies: workable, efficient, essential

PAINT1 study

The PAINT1 study is accomplished. Using a cross-over study design and the written readability test, the PAINT1 study investigated five original and five model package inserts with 1105 participants.

Many package inserts have shortcomings

Original German title: Viele Packungsbeilagen weisen Mängel auf

Package inserts for medicines - patients' requirements versus the reality

Original German title: Die Packungsbeilage von Arzneimitteln - Patientenwünsche und Realität

Design of package inserts for medicines

Original German title: Gestaltung von Packungsbeilagen für Arzneimittel

1999

Dr. Jörg Fuchs commences intensive research and scientific studies into package inserts and readability tests

News

DGRA-Workshop - Productinformation and Labelling
Forum Seminar: Product information texts
Readability test results from the PAINT3 study: Should package leaflets be coloured in the future?

Last update: 15.08.2019

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